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临床试验/NCT02762461
NCT02762461已完成不适用

Artificial Reproductive Techniques (ART) and Progression of Endometriosis Symptoms

University of Aarhus1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
154
试验地点
1
主要终点
Endometriosis Health Profile 30® (EHP-30®)

研究概览

简要总结

This project will investigate worsening of symptoms in endometriosis patients undergoing artificial reproductive techniques (ART). The study compares patients with peritoneal/ovarian and deep infiltrating endometriosis to relevant reference groups. Symptoms are monitored with a questionnaire with the categories quality of life, pain and bowel habits. The EHP-30® questionnaire is included in the questionnaire.

详细描述

Endometriosis affects up to 10% of all fertile women, and is associated with symptoms like infertility, dysmenorrhea, deep dyspareunia and chronic pelvic pain. 10-25% of endometriosis patients need artificial reproductive techniques (ART) to become pregnant. Endometriosis is estrogen dependent, and in theory this means, that the increased levels of estrogen during fertility treatment will worsen endometriosis symptoms. Endometriosis is a benign disease, and treatment is guided by the patient's symptoms. Worsening of endometriosis symptoms during fertility treatment may result in cessation of the treatment, operation and risk of complications.

This project will investigate worsening of symptoms in endometriosis patients undergoing artificial reproductive techniques (ART). The study compares endometriosis patients undergoing ART to two relevant reference groups; one group consisting women undergoing ART with infertility because of factors other than endometriosis, and one group consisting women with medically treated endometriosis not undergoing ART. Symptoms of endometriosis during ART will be monitored using a questionnaire that among other questions includes the validated questionnaire Endometriosis Health Profile 30® (EHP-30®). The questionnaire is administered before starting ART and later in the cycle before the patient gets to know if she is pregnant. The questionnaires as well as data collection will be administered electronically in REDCap® which is a secure web application for building and managing online surveys and databases.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 40 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • < 40 years
  • Either undergoing ART (IVF or ICSI) with or without endometriosis or medically treated endometriosis

排除标准

  • > 40 years

结局指标

主要结局

Endometriosis Health Profile 30® (EHP-30®)

时间窗: Groups undergoing ART: Change from baseline measures before stimulation during ART to ten days after aspiration. Reference group not undergoing ART: Change from baseline measures to four weeks later.

The core instruments have five scale scores covering: Pain (11 questions), control and powerlessness (6 questions), social support (4 questions), emotional well-being (6 questions), self-image (3 questions).

次要结局

  • Bowel habits(Groups undergoing ART: Change from baseline measures before stimulation during ART to ten days after aspiration. Reference group not undergoing ART: Change from baseline measures to four weeks later.)
  • Pain (NRS scale: 0-10)(Groups undergoing ART: Change from baseline measures before stimulation during ART to ten days after aspiration. Reference group not undergoing ART: Change from baseline measures to four weeks later.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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